Status:
COMPLETED
Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
Lead Sponsor:
NIZO Food Research
Collaborating Sponsors:
FrieslandCampina
Conditions:
Infection
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Rationale: Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the pote...
Eligibility Criteria
Inclusion
- Age 18-50 yr
- Signed informed consent
- Availability of internet connection
- Male or female
- Willing to stop blood donation at the blood bank during the study period
Exclusion
- Currently participating in another clinical trial
- Previous Cholera, Salmonella, or E. coli vaccination
- Tonsillectomy
- Acute gastroenteritis in the past 2 months
- Use of antibiotics in the past 2 months
- Hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts)
- Pregnancy or lactating (pregnancy test will be performed on the vaccination days)
- Not willing to drink raw milk
- Allergic to milk or lactose-intolerant
- Disease of GI tract, liver, gall bladder, kidneys, thyroid gland
- Immune-compromised
- Use of immunosuppressive drugs
- Drug abuse, and not willing/able to stop this during the study
- Excessive alcohol usage (men: \>4 consumptions/day or \>20 consumptions/week; women: \>3 consumptions/day or \>15 consumptions/week)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02238548
Start Date
July 1 2014
End Date
December 1 2016
Last Update
March 29 2017
Active Locations (1)
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1
NIZO food research
Ede, Netherlands, 6718 ZB